產品標準在現今社會中扮演非常重要的角色，但也容易造成許多技術性貿易障礙。醫藥產品由於攸關人類身體的健康及安全，因此相較於其他行業，各國對藥品皆設有許多嚴格的產品標準及技術法規，對藥品的國際貿易產生嚴重的技術性貿易障礙。PIC/S制定共通的GMP標準，並且旨在降低醫藥產品在國際貿易及流通上所面臨的非關稅貿易障礙。台灣藥物食品檢驗局於2007年公告實施PIC/S GMP，預計於2013年開始全面實施。本研究關注的核心議題，主要將以WTO對技術性貿易障礙的主要規範原則，分析探討PIC/S降低醫藥產品技術性貿易障礙的功能。另外，台灣製藥業由於缺乏關鍵技術、藥廠家數眾多、生產規模小，惡性競爭十分激烈，未來實施PIC/S GMP後，對我國製藥業的衝擊不容小覷，因此本研究另一項主要議題是PIC/S GMP對我國製藥業及藥品貿易之可能影響。 / Product standards play an important role in modern societies. However, they also raise many concerns about technical barriers to trade, particularly for pharmaceutical products which must comply with numerous stringent product standards, such as GMP standards. Therefore, PIC/S aims at reducing the technical barriers to pharmaceutical trade by providing a common GMP standard, which the Bureau of Food and Drug Analysis of Taiwan declared to introduce PIC/S GMP in 2007, and to fully enforce in 2013. This study will examine how PIC/S decreases technical barriers to trade for pharmaceutical products with principals in the WTO TBT Agreement. In addition, since Taiwan pharmaceutical industry has low competitiveness for a long time, how PIC/S GMP will affect the pharmaceutical industry and international trade of Taiwan is another main issue of this study.

SOCIAL INNOVATION AND DESIGN CHALLENGES:Einleitung Zwischen Standesdünkel und Gendergap - Die Etablierung der medizinischen Schutzmaske und frühe gestalterische Experimente Von vielfältigen Konzepten zum total Disposable System - Die Etablierung der heutigen Form Vom Innovationstreiber zur Bremse - Normen und Normierungsverfahren Designende als Vermittelnde - Die Einbindung unterschiedlicher Akteur*innen Acknowledgements Referenzen / In diesem Beitrag werden die Gestaltungspraxen medizinischer Schutzmasken und die sie begleitenden Diskurse in den Blick genommen. Es soll gefragt werden, wie sich ihr Gestaltungsrahmen begründet, welche Akteur*innen am Design beteiligt waren und welche ihre Interessen durchsetzen konnten. Es wird zu zeigen sein, dass selbst bei einem alltäglichem Gut wie der Schutzmaske, deren Kernauftrag vermeintlich klar und wenig diskutabel erscheint, vor allem soziale und kulturelle Mechanismen das Design determinieren. Dabei arbeitet dieser Beitrag aus einer historischen Perspektive. Er nimmt die Designgeschichte der Schutzmaske seit ihrer theoretischen Einführung in die Medizin am Ende des 19. Jahrhunderts in den Blick. Als Quellengrundlage wird dazu auf historische Entwurfszeichnungen von Schutzmasken sowie auf den medizinischen Fachdiskurs des 20. Jahrhunderts zurückgegriffen. Ausgehend von Beobachtungen in einem Forschungsprojekt an der HSLU (2021– 2023), welches ein grundlegendes Redesign der Schutzmaske im Sinne der Nachhaltigkeit anstrebte, werden zudem aktuelle Grenzen und Möglichkeiten bei der Gestaltung sowie der Einbindung unterschiedlicher Anspruchsgruppen eruiert.:Einleitung Zwischen Standesdünkel und Gendergap - Die Etablierung der medizinischen Schutzmaske und frühe gestalterische Experimente Von vielfältigen Konzepten zum total Disposable System - Die Etablierung der heutigen Form Vom Innovationstreiber zur Bremse - Normen und Normierungsverfahren Designende als Vermittelnde - Die Einbindung unterschiedlicher Akteur*innen Acknowledgements Referenzen

The exceeding supply over demand and very hard competitive conditions are nowadays the main features of the majority of sectors. A successful company is the one that is able to satisfy specific customers' needs, the one that has efficient cooperation with its suppliers throughout the whole supply chain and also the one that is able to speed up the in-house information exchange. Thus the company has to seek constantly new and innovative solutions. This is not possible without standardization and automatization of business processes. This master's thesis is dedicated to one of the possible solutions -- the Product Information Management (PIM). Since it is intended for business managers (without deep IT knowledge), at the beginning it answers the question why it is so important to know master data and to manage it. It specializes in managing product data, brings its comprehensive overview and identifies the advantages and drawbacks of the implementation as well as financial and organizational impacts. The consecutive chapter deals with simplified yet applicable approach to data management analysis (with emphasis on the PIM) and based on research, it mentions main mistakes of the implementation. In addition to the overview of main vendors of the PIM solution, it presents the latest trends in the PIM. Besides internal data synchronization, the thesis analyses several product standards -- the fundamental step towards external data synchronization, the key topic of the practical part. The whole thesis is conceived to provide an organization with a simple yet compact and therefore very effective tool for master product data insight and thus to help it to gain a competitive advantage.

The Agricultural Product Standards Act, 1990 (Act 119 of 1990) of South Africa provides for the standardisation of quality norms for agricultural produce (DAFF, 2018). The purpose of this research was to investigate the quality and compliance of fresh produce sold in the Tshwane metropolis with the Agricultural Product Standards Act of South Africa. A cross-sectional study survey was conducted in six regions of Tshwane metropolis, in which 200 fresh produce vendors were randomly selected from various vending sites to analyse their level of knowledge regarding the Act. Furthermore, different fruits and vegetables were sampled from different vending sites and inspected for compliance with the Act.The vast majority (89%) of respondents did not know of the existence of the Act. Quite a small proportion of fruit (51.5 %) and vegetable (56 %) retailers indicated that their agricultural fruit products have been monitored. A large proportion of fruits (from 86% to 99.8%) and vegetables (from 85.4% to 97.5%) met all the various quality requirements. In general a fair proportion of fruits (58%) and vegetables (65%) complied highly with the Act in terms of quality. There was a significant positive correlation between monitoring by officials and the level of compliance. The Department of Agriculture Forestry and Fisheries should make sure that farmers and street vendors of agricultural produce register their businesses and are trained on the interpretation of the provisions of the Agricultural Product Standards Act. This will allow them to be tracked and traced for proper development concerning matters related to the Act. / Life and Consumer Sciences / M.A. (Consumer Science)